A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis

The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy. In this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.

NCT Number	NCT06174922
Lead Sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions	Allergic Bronchopulmonary Aspergillosis
Enrollment	300 participants
Start Date	2023-12-01
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-02-28